HRPP Newsletter – June 2024
Update on Care Everywhere and Research Uses
Information can only be requested through Care Everywhere for providing treatment to a patient. Information may not be requested specifically for research purposes, except when limited to participant safety as described below. To clarify, UW Health has confirmed with Epic that information acquired through a query (when Health Link automatically asks Care Everywhere what documents/information are available) or through a download (when a clinician, in order to provide treatment to a patient, asks Care Everywhere to obtain the document/information it said was available) CAN be used for research purposes because it is already viewable in the EMR and was requested originally for treatment purposes. It may be acceptable to query or download from Care Everywhere for treatment or care coordination for a research participant. For example, a patient has an adverse event documented at a non-UW Health facility that requires a study provider (a clinician) to download information to determine if they should discontinue study drug for safety reasons.
Update to Considerations for Industry Funded Studies Reviewed Locally
Fully industry sponsored studies are reviewed by an independent IRB except for limited exceptions including:
- Investigator- initiated studies funded by industry grants, which may be reviewed by a UW IRB. As these funding mechanisms are similar to other external grants, no fee for IRB review is charged.
- Statistical Data or Reading Center studies can be reviewed by a UW IRB. As these are fully industry sponsored, review fees will be charged beginning with studies approved after July 1, 2024.
- Exceptions can be made for other single-site, fully industry sponsored studies with approval from the IRB. Email IRBdirector@hsirb.wisc.edu to request an exception. These studies will be charged fees for review by a UW IRB.
Visit the IRB fee schedule for more information.
Office Hours and Presentations for ARROW Upgrade
As mentioned in the May newsletter, ARROW will be undergoing an upgrade on August 10th. This upgrade includes changes to navigation of the application and reviewer notes. We will have dedicated virtual office hours (no registration required) and presentations (registration required) related to these updates. Please see dates and times below.
Offices Hours: Thursday, July 25th and Thursday, August 22nd, 12-1pm. You can log in to the Zoom session here.
Presentations: Monday, July 15th at 2:00 pm. Register for this date here. Wednesday, August 14th at 10:00 am. Register for this date here.
Reminder When Placing Orders for Research Procedures
It is the responsibility of research teams to ensure that informed consent has been obtained from subjects prior to any research procedure, including labs and imaging procedures. If a research procedure is completed (e.g. research blood draw) before consent is obtained due to orders being placed prior to a consenting visit, this must be reported to the IRB as noncompliance.
Reminder to Remove Key Personnel No Longer on Studies or at UW-Madison
Being listed as key personnel on an ARROW application triggers compliance notifications to individuals, such as human subjects training, HIPAA training, and completion of the outside activity report. This can create confusion as well as unnecessary work for staff. If an individual is no longer acting as key personnel on a study or has left the UW, please remove such individual using the self-service tool for personnel updates or through a Change of Protocol.